Ontrak 015-0118-05Q

GUDID 10841522129247

CUFF,ABP,CHILD,12-20CM/5-8IN,NO LTX

SPACELABS HEALTHCARE (WASHINGTON), INC

Blood pressure ambulatory recorder

• Primary Device ID: 10841522129247
• NIH Device Record Key: 5b0557d3-ba17-405c-a243-5a7cc6b5ff3f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ontrak
• Version Model Number: ABP Cuffs and Cuff Covers
• Catalog Number: 015-0118-05Q
• Company DUNS: 145581588
• Company Name: SPACELABS HEALTHCARE (WASHINGTON), INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10841522129247 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141113

FDA Product Code

• DXN: System, measurement, blood-pressure, non-invasive

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-06-17
• Device Publish Date: 2024-06-07

On-Brand Devices [Ontrak]

• 10841522102547: CUFF,ABP,XLGADLT,38-50CM/15-20IN,NO LTX,QKD/LEUR
• 10841522102530: CUFF,ABP,LG ADLT,32-42CM/13-17IN,NO LTX,QKD/LUER
• 10841522102257: CUFF,ABP,CHILD,12-20CM/5-8IN,NO LTX,QK DISC/LUER
• 10841522102240: CUFF,ABP,ADLT,24-32CM/9-13IN,NO LTX,QK DISC/LUER
• 10841522102233: CUFF,ABP,SM ADLT,17-26CM/7-10IN,NO LTX,QKD/LUER
• 10841522129261: CUFF,ABP,ADULT,XL,38-50CM/15-20IN,NO LTX
• 10841522129247: CUFF,ABP,CHILD,12-20CM/5-8IN,NO LTX